Download Letter of Agreement for Contributed Funds

LETTER OF AGREEMENT
FOR CONTRIBUTED FUNDS
The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is committed to presenting
continuing education activities to physicians, pharmacists, nurses, and dietitians that promote
improvements or quality in healthcare and are independent of the control of commercial interests. As
part of this commitment, A.S.P.E.N. has outlined in this written agreement the terms, conditions, and
purposes of commercial support for its continuing education activities. Commercial Support is defined
as financial, or in-kind, contributions given by a commercial interest, that are used to pay all or part of
the costs of a continuing education activity.
REGARDING TERMS, CONDITIONS AND PURPOSES OF CONTRIBUTED FUNDS
1. Between A.S.P.E.N., an accredited provider (Provider) of continuing education for ACCME, ACPE,
ANCC/COA, and CDR, and
(Company)
2. Title of Continuing Education Activity (Program)
3. Continuing Education Activity Location
4. Continuing Education Activity Date (s)
5. Please identify the purpose contributed funds and amounts below
Unrestricted educational contribution for support of the continuing education activity in the
amount of $___________
Contribution in the amount of $________________________for the following purposes:
1)
2)
3)
4)
Support for catering functions in the amount of $____________________ for a specific event
(Specify)
In-kind contribution (e.g., equipment loan, brochure distribution) in the amount of
$______________ (specify)
Payment is due 30 days after execution of this contract.
[*The ACCME defines a Commercial Interest (the Company) as any proprietary entity producing, marketing, reselling, distributing or otherwise participating in or profiting from the distribution, promotion or sale of health
care good or services consumed by, or used on, patients, with the exemption of non-profit, insurance,
government organizations, and non-health-care-related companies. The ACCME does not consider providers of
clinical service directly to patients to be commercial interest.]
TERMS, CONDITIONS, AND PURPOSES
A.S.P.E.N. is responsible for all decisions regarding this educational activity, and cannot accept advice or services
from the company as a condition of receiving this contribution. The Company may not stipulate the manner in
which A.S.P.E.N. will fulfill any accreditation requirements.
Independence
1. This activity is for scientific and educational purposes only and will not promote any specific proprietary
business interest of the Company.
Appropriate Use of Commercial Support
2. A.S.P.E.N. will make all decisions regarding the disposition and disbursement of funds from the
Company.
3. All commercial support associated with this activity will be given with the full knowledge and approval
of A.S.P.E.N. No other payments shall be given to the director of the activity, planning committee
members, teachers or authors, joint sponsor, or any others involved with the supported activity.
4. A.S.P.E.N. will, upon request, furnish the Company documentation detailing the receipt and expenditure
of the commercial support.
Commercial Promotion
5. Product promotion material /product advertisement of any type is prohibited in or during the continuing
education activity. The juxtaposition of editorial and advertising material on the same products or
subjects is not allowed. Promotional materials may not be displayed or distributed in the educational
space immediately before, during or after a continuing education activity. Company may not engage in
sales or promotional activities while in the space or place of the continuing education activity.
6. Company may not be the agent providing the continuing education activity to the learners.
Disclosure
7. A.S.P.E.N. will ensure that the source of support from the Company, either direct or “in-kind”, is
disclosed to the participants, in program brochures, syllabi, and/or other program materials, and at the
time of the activity. Disclosure will not include the use of trade name or a product-group message.
Acknowledgement of commercial support may state the name, mission, and clinical involvement of the
company and may include corporate logos and slogans, if they are not product promotional in nature.
The Company and A.S.P.E.N. agree to abide by all requirements of the Accreditation Council for
Continuing Medical Education (ACCME) Standards for Commercial Support of Continuing Medical
Education (attached).
Accredited Provider: A.S.P.E.N.
Contact Person: Carol Woodside
Phone Number: 301-920-9146
American Society for Parenteral & Enteral
Nutrition
8630 Fenton Street Suite 412 Silver Spring MD
20910
Email Address: [email protected]
Fax: 301-587-2365
Contributing Company:
Address:
City, State, Zip:
Contact Person:
Phone Number:
Email Address:
Fax:
Agreed by Authorized Representatives
Contributing Company:
Signature __________________________________
Date ______________________________________
Print Name ________________________________
Title ______________________________________
A. S.P.E.N.
Signature ___________________________________
Date _______________________________________
Print Name
Debra Ben Avram_________
Title
Chief Executive Officer_________
Tax ID Number: 521161382
ACCREDITATION COUNCIL FOR CONTINUING MEDICAL EDUCATION STANDARDS FOR
COMMERCIAL SUPPORT OF CONTINUING MEDICAL EDUCATION (2004)
ACCME Standard 1. Independence.
1.1 ACCME provider must ensure that the following decisions were made free of the control of a commercial
interest. The ACCME defines a “Commercial interest” as any proprietary entity producing health care
goods or services, with the exemption of non-profit or government organizations and non-health care
related companies.
a. Identification of CME needs;
b. Determination of educational objectives;
c. Selection and presentation of content;
d. Selection of all persons and organizations that will be in a position to control the content of the
CME;
e. Selection of educational methods;
f. Evaluation of the activity.
1.2 A commercial interest cannot take the role of non-accredited partner in a joint sponsorship relationship.
2. ACCME Standard 2: Resolution of personal conflicts of interests.
2.1 The provider must be able to show that everyone who is in a position to control the content of an
education activity has disclosed all relevant financial relationships with any commercial interest to the
provider. The ACCME defines “relevant” financial relationships as financial relationships in any amount
occurring within the past 12 months that create a conflict of interest.
2.2 An individual who refuses to disclose relevant financial relationships will be disqualified from being a
planning committee member, a teacher, or an author of CME, and cannot have control of, or
responsibility for, the development, management, presentation or evaluation of the CME activity.
2.3 The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to
the education activity being delivered to learners.
3. ACCME Standard 3: Appropriate use of commercial support.
3.1 The provider must make all decisions regarding the disposition and disbursement of commercial support.
3.2 A provider cannot be required by a commercial interest to accept advice or services concerning teachers,
authors, or participants or other education matters, including content, from a commercial interest as
conditions of contributing funds or services.
3.3 All commercial support associated with a CME activity must be given with the full knowledge and
approval of the provider.
Written agreement documenting terms of support
3.4 The terms, conditions, and purposes of the commercial support must be documented in a written
agreement between the commercial supporter that includes the provider and its educational partner(s).
The agreement must include the provider, even if the support is given directly to the provider’s
educational partner or a joint sponsor.
3.5 The written agreement must specify the commercial interest that is the source of commercial support.
3.6 Both the commercial supporter and the provider must sign the written agreement between the
commercial supporter and the provider.
Expenditures for an individual providing CME
3.7 The provider must have written policies and procedures governing honoraria and reimbursement of outof-pocket expenses for planners, teachers and authors.
3.8 The provider, the joint sponsor, or designated educational partner must pay directly any teacher or
author honoraria or reimbursement of out-of-pocket expenses in compliance with the provider’s written
policies and procedures.
3.9 No other payment shall be given to the director of the activity, planning committee members, teachers or
authors, joint sponsor, or any others involved with the supported activity.
3.10 If teachers or authors are listed on the agenda as facilitating or conducting a presentation or session, but
participate in the remainder of an educational event as a learner, their expenses can be reimbursed and
honoraria can be paid for their teacher or author role only.
Expenditures for learners
3.11 Social events or meals at CME activities cannot compete with or take precedence over the educational
events.
3.12 The provider may not use commercial support to pay for travel, lodging, honoraria, or personal
expenses for non-teacher or non-author participants of a CME activity. The provider may use
1.
commercial support to pay for travel, lodging, honoraria, or person expenses for bona fide employees
and volunteers of the provider, joint sponsor or educational partner.
Accountability
3.13 The provider must be able to produce accurate documentation detailing the receipt and expenditure of
the commercial support.
4. ACCME Standard 4: Appropriate Management of Associated Commercial Promotion
4.1 Arrangements for commercial exhibits or advertisements cannot influence planning or interfere with the
presentation, nor can they be a condition of the provision of commercial support for CME activities.
4.2 Product-promotion material or product-specific advertisement of any type is prohibited in or during
CME activities. The juxtaposition of editorial and advertising material on the same products or subjects
must be avoided. Live (Staffed exhibits, presentations) or enduring (printed or electronic
advertisements) promotional activities must be kept separate from CME.
 For print, advertisements and promotional materials will not be interleafed within the pages of the
CME content. Advertisements and promotional materials may face the first or last pages of printed
CME content as long as these materials are not related to the CME content they face and are not
paid for by the commercial supporters of the CME activity.
 For computer based, advertisements and promotional materials will not be visible on the screen at
the same time as the CME content and not interleafed between computer “windows” or screens of
the CME content.
 For audio and video recording, advertisements and promotional materials will not be included
within the CME. There will be no “commercial breaks.”
 For live, face-to-face CME, advertisements and promotional materials cannot be displayed or
distributed in the educational space immediately before, during, or after a CME activity. Providers
cannot allow representatives of Commercial Interests to engage in sales or promotional activities
while in the space or place of the CME activity.
4.3 Educational materials that are part of a CME activity, such as slides, abstracts and handouts, cannot
contain any advertising, trade name or a product-group message.
4.4 Print or electronic information distributed about the non-CME elements of a CME activity that are not
directly related to the transfer of education to the learner, such as schedules and content descriptions,
may include product-promotion material or product-specific advertisement.
4.5 A provider cannot use a commercial interest as the agent providing a CME activity to learners, e.g.,
distribution of self-study CME activities or arranging for electronic access to CME activities.
5. ACCME Standard 5: Content and Format free of commercial bias.
5.1 The content or format of a CME activity or its related materials must promote improvements or quality in
healthcare and not a specific proprietary business interest of a commercial interest.
5.2 Presentations must give a balanced view of therapeutic options. Use of generic names will contribute to
this impartiality. If the CME educational material or content includes trade names, where available trade
names from several companies should be used, not just trade names from a single company.
6. ACCME Standard 6: Disclosures Relevant to Potential Commercial Bias.
Relevant financial relationships of those with control over CME content
6.1 An individual must disclose to learners any relevant financial relationship(s), to include the following
information:
 Name of the individual;
 Name of the commercial interest(s);
 Nature of the relationship the person has with each commercial interest.
6.2 For an individual with no relevant financial relationship(s), the learners must be informed that no
relevant financial relationship(s) exist.
Commercial support for the CME activity
6.3 The source of all support from commercial interests must be disclosed to learners. When commercial
support is “in-kind”, the nature of the support must be disclosed to learners.
6.4 “Disclosure” must never include the use of a trade name or a product-group message.
Timing of disclosure
6.5 A provider must disclose the above information to learners prior to the beginning of the educational
activity.